Catheter Insertion Device Including Retractable Needle

ABSTRACT

A catheter insertion device for inserting a catheter into a body of a patient is disclosed. The catheter insertion device includes a retractable needle for establishing access to a subcutaneous vessel of the patient and a manually extensible guidewire for guiding the initially attached catheter into the vessel. In one embodiment, the catheter insertion device comprises a housing, a hollow needle retractably extending from the housing, a catheter initially disposed on a portion of the needle, a guidewire including a portion initially disposed within the needle, a guidewire advancement feature configured to selectively advance a distal end of the guidewire distally past a distal end of the needle, and a needle retention component configured to selectively enable retraction of the needle into the housing. The needle retention component is configured to be actuated by the guidewire advancement feature. In one embodiment, one-handed operation of the device is possible.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/295,906, filed Mar. 7, 2019, now U.S. Pat. No. 11,033,719, which is acontinuation of U.S. patent application Ser. No. 14/846,387, filed Sep.4, 2015, now U.S. Pat. No. 10,232,146, which claims the benefit of U.S.Provisional Patent Application No. 62/046,722, filed Sep. 5, 2014, andtitled “Guidewire-Assisted Catheter Insertion Device,” each of which isincorporated by reference in its entirety into this application.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa catheter insertion device for inserting a peripheral IV (“PIV”) orother suitable catheter into a body of a patient. The catheter insertiondevice includes a retractable needle for establishing access to asubcutaneous vessel of the patient and a manually extensible guidewirefor guiding the catheter, initially attached to the catheter insertiondevice, into the vessel. In one embodiment, one-handed operation of thedevice is possible.

In one embodiment, therefore, the catheter insertion device comprises ahousing, a hollow needle retractably extending from the housing, acatheter initially disposed on a portion of the needle, a guidewireincluding a portion initially disposed within the needle, a guidewireadvancement feature configured to selectively advance a distal end ofthe guidewire distally past a distal end of the needle, and a needleretention component configured to selectively enable retraction of theneedle into the housing. The needle retention component is configured tobe actuated by the guidewire advancement feature.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIGS. 1A-1F show various views of a catheter insertion device accordingto one embodiment;

FIG. 2 is a perspective view of a needle hub assembly of the catheterinsertion device of FIGS. 1A-1F;

FIG. 3 is a side view of a plate of the catheter insertion device ofFIGS. 1A-1F;

FIGS. 4A and 4B are side views of the catheter insertion device of FIGS.1A-1F;

FIG. 5 is a perspective view of a distal portion of the catheterinsertion device of FIGS. 1A-1F;

FIGS. 6A-6E shows various views of a catheter insertion device accordingto one embodiment;

FIGS. 7A and 7B are various cutaway views of the catheter insertiondevice of FIGS. 6A-6E;

FIG. 8 is a top cutaway view of the catheter insertion device of FIGS.6A-6E;

FIGS. 9A and 9B are various views of a catheter assembly according toone embodiment;

FIG. 10 is an end view of a catheter assembly according to oneembodiment; and

FIG. 11 is a side view of a catheter assembly according to oneembodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to acatheter insertion device for inserting a peripheral IV (“PIV”) or othersuitable catheter into a body of a patient. The catheter insertiondevice includes a retractable needle for establishing access to asubcutaneous vessel of the patient, for instance, and a manuallyextensible guidewire for guiding the catheter, initially attached to thecatheter insertion device, into the vessel. In one embodiment,one-handed operation of the device is possible.

FIGS. 1A-1F depict various views of a catheter insertion device(“device”) 10 according to one embodiment. As shown, the device 10includes a housing 12 defined by a top housing portion 12A and a bottomhousing portion 12B, though it is appreciated that the housing can beintegrally formed as a single piece or include more than two portions,in other embodiments.

A hollow needle 14 initially and distally extends from a distal portionof the housing 12 and includes a distal end 14B that is configured toestablish an insertion site for a catheter through the skin and vesselof the patient, in the present embodiment. A needle hub 16 is disposedin the housing 12 and secures the needle. A flash chamber 17 is includedin the needle hub 16 and a proximal end 14A of the needle 14 is disposedtherein so as to allow blood to enter the flash chamber when needleaccess to a vessel of the patient is established. The flash chamber 17and adjacent portions of the housing 12 are translucent in oneembodiment to enable clinician observation of blood when present in theflash chamber.

FIG. 2 gives additional details of the needle hub 16. As shown, theneedle hub 16 further includes a distal, conical nose portion 19 thatinitially extends from the distal end of the housing 12 (FIG. 1C). Areduced-diameter neck 52 is included between the nose portion 19 and amore proximal, cylindrical portion of the needle hub 16.

A spring 18 is interposed between the flash chamber 17 and a distalportion of the housing 12 to enable selective retraction of the needle14 fully into the housing so as to prevent accidental needle sticksafter use of the device 10. Note that the size, type, position, andorientation of the spring is but one of various possible springconfigurations. In addition, other resilient features or retractionmechanisms can be employed to selectively retract the needle into thehousing.

A catheter assembly 60, including an elongate catheter tube 62 definingone or more lumens and a hub 64, is initially disposed over the needle14 such that needle is received into the lumen of the catheter tube, asshown in FIG. 1A. Note that the catheter assembly 60 has been removedfrom various of the figures to be discussed herein, for clarity.

The device 10 in the present embodiment includes a guidewire advancementassembly for selectively advancing a guidewire 22 that is initiallydisposed both within the housing 12 and within a lumen defined by thehollow needle 14. As best seen in FIG. 1F, a proximal end of theguidewire 22 is attached to a guidewire hub 28 such that the guidewireextends distally into the flash chamber 17, through the proximal end 14Aof the hollow needle 14, and into the lumen defined by the needle. Theguidewire hub 28 includes two fins 30 that extend in opposite directionsfrom one another and are configured to be slidably received incorresponding tracks 32 that are defined in a guidewire advancementhandle 20, best seen in FIGS. 1C and 1D. The arrangement of the fins 30and tracks 32 enable the guidewire hub 28 to separate from the guidewireadvancement handle 20, as will be described further below.

In greater detail, the guidewire advancement handle 20 is slidablyattached to the housing 12 so as to selectively advance or retract theguidewire 22. The guidewire advancement handle 20 includes a rail 26that is disposed in a slot 24 of the top portion 12A of the housing 12so as to enable the guidewire advancement handle to slide proximally anddistally along the slot. A finger pad 21 is included on the guidewireadvancement handle 20 to enable a user of the device 10 to selectivelyslide the guidewire advancement handle. Note that the size, shape,position, and configuration of the guidewire advancement handle 20 andfinger pad 21 can vary from what is explicitly shown and describedherein.

So configured, distal advancement of the guidewire 22 is accomplished bya user placing a finger on the finger pad 21 of the guidewireadvancement handle 20 and sliding it from an initial proximal positionto a more distal position with respect to the housing 12. This distaladvancement of the guidewire advancement handle 20 also advances boththe guidewire hub 28, which is removably attached to the guidewireadvancement handle via the tracks 32 that receive the guidewire hub fins30, as already described, and the guidewire 22 itself such that a distalportion thereof extends out of and distally past the distal end 14B ofthe needle 14. Note that other guidewire advancement handle and fingerpad designs and configurations are possible in addition to thosedescribed herein.

A needle retention assembly is also included and in the presentembodiment includes a needle retention component 40 to selectivelyenable retraction of the needle 14 into the housing after use of thedevice 10 so as to protect the user from an accidental needle stick. Inthe present embodiment, the needle retention component 40 includes aplate 42 that is movably disposed in a slot 46 defined at the distal endof the housing 12, as seen in FIGS. 1B-1F.

In greater detail and as seen in FIG. 3, the plate 42 defines a keyhole44 that includes a semicircular portion 44A and a circular portion 44B,as shown. As seen in FIG. 1B, the plate 42 is initially placed in theslot 46 of the housing 12 in an un-depressed position such that theneedle hub 16 extends through the keyhole 44. Specifically, thesemicircular portion 44A of the keyhole 44 receives the neck 52 of theneedle hub 16 such that the needle hub seats in the keyhole. Note that,in one embodiment, a spring or other component can be employed tomaintain the plate 42 in the un-depressed position shown in FIG. 1B.

The plate 42 further includes an angled surface 48 (also referred toherein as a second angled surface) on a top edge thereof such that theangled face faces proximally. The angled surface 48 is configured tointeract with a distally-facing angled surface 34 (also referred toherein as a first angled surface) disposed on the distal end of theguidewire advancement handle 20 when the guidewire advancement handle isdistally advanced to distally extend the guidewire 22 out the distal end14B of the needle 14, as will be further detailed below. Note that theangle, direction, shape, and other configuration of the first and secondangled faces can vary from what is shown and described herein. Forinstance, in one embodiment the direction of the angled faces could bereversed from what is shown here. In another embodiment, the first andsecond angled surfaces can be replaced with engagement surfaces thatinteract to cause retraction of the needle into the housing.

The selective retraction of the needle 14 via actuation of the needleretention assembly described above is described here in connection withuse of the device 10 to insert a catheter or other suitable tubulardevice the body of a patient, according to one embodiment and asdepicted in FIGS. 4A and 4B. During operation, the needle 14 is firstused to pierce through an insertion site on the skin surface of thepatient and extend the distal end 14B of the needle into a subcutaneousvessel (or other intended destination). The guidewire advancement handle20 is then slid distally from its proximal position with respect to thehousing 12 so as to extend the guidewire 22 out the open distal end ofthe needle 14 and into the vessel. The guidewire 22 distally advances inthis manner until the guidewire hub 28 contacts a proximal end 17A ofthe flash chamber 17, which ceases further distal guidewire movement.This is generally shown in FIG. 4A. The catheter assembly 60 can then bemanually and distally advanced from the device 10 and inserted into thevessel, guided by the needle 14 and the guidewire 22.

The device 10 can then be retracted away from the patient. At this time,the guidewire advancement handle 20 is slid further distally along theslot 24 in the top housing portion 12A. As the guidewire advancementhandle 20 slides distally, the guidewire hub 28—abutting the proximalend 17A of the flash chamber 17 as described above—separates from theguidewire advancement handle via its fins 30 sliding out of the tracks32 (FIG. 1D) as the guidewire advancement handle distally advances. Theguidewire advancement handle 20 continues to slide distally until itsfirst angled surface 34 engages and pushes down on the second angledsurface 48 of the plate 42—the needle retention component 40 of thepresent embodiment. This causes the plate 42 to move from theun-depressed position shown in FIGS. 1B, 4A, and 5 to the depressedposition shown in FIG. 4B. In turn, this causes the neck 52 of theneedle hub 16 to unseat from the semicircular portion 44A of the platekeyhole 44 and to align with the circular portion 44A thereof.

No longer constrained by the plate 42, the needle hub 16 can now retractproximally within the housing, urged by the force of the spring 18,which can now expand from a compressed state (FIG. 5) to an expandedstate (FIG. 4B). Retraction of the needle hub 16 causes thecorresponding retraction of the needle 14 into the housing 12 until thedistal end 14B thereof is disposed within the housing so as to preventaccidental needle sticks to the user. The proximal retraction of theneedle hub 16 and connected flash chamber 17 correspondingly causes theguidewire hub 28 to also retract, given its abutment against theproximal end 17A of the flash chamber. This will correspondingly causeretraction of the guidewire 22 a predetermined amount. In oneembodiment, the guidewire can be fully retracted into the housing. Thenow-placed catheter assembly 60 can then be dressed and the device 10disposed of or otherwise safely handled.

In one embodiment, it is appreciated that detents or other features canbe used to provide an aural and/or tactile cue when the guidewireadvancement handle has advanced the guidewire to its full distaldistance, when the guidewire advancement handle itself has advanced itsfull distal distance, and/or when other points along the travel pathhave been reached by the guidewire advancement handle. It is furtherappreciated that the device 10 of the present embodiment can be operatedby only one hand of the user, thus facilitating ease-of-use.

FIGS. 6A-6E depict various views of the catheter insertion device(“device”) 10 according to another embodiment. As shown, the device 10includes a housing 112 defined by a top housing portion 112A and abottom housing portion 112B, though it is appreciated that the housingcan be integrally formed as a single piece or include more than twoportions, in other embodiments.

A hollow needle 114 initially and distally extends from a distal portionof the housing 112 and includes a distal end 114B that is configured toestablish an insertion site for a catheter through the skin and vesselof the patient, in the present embodiment. A needle hub 116 is disposedin the housing 112 and secures the needle. A flash chamber 117 isincluded in the needle hub 116 and a proximal end 114A of the needle 114is disposed therein so as to allow blood to enter the flash chamber whenneedle access to a vessel of the patient is established. As before, theflash chamber and adjacent portions of the housing 112 are translucentin one embodiment to enable clinician observation of blood when presentin the flash chamber.

A spring 118 is interposed between the flash chamber 117 and a distalportion of the housing 112 to enable selective retraction of the needle114 fully into the housing so as to prevent accidental needle sticksafter use of the device 10. Note that the size, type, position, andorientation of the spring is but one of various possible springconfigurations. In addition, other resilient features or retractionmechanisms can be employed to selectively retract the needle into thehousing.

The catheter assembly 60, including the elongate catheter tube 62 andthe hub 64, is initially disposed over the needle 114 such that needleis received into the lumen of the catheter tube, as shown in FIG. 6A.The catheter assembly 60 is removably attached to the device 10 in amanner to be described further below. Note that the catheter assembly 60has been removed from various of the figures to be discussed herein, forclarity.

The device 10 in the present embodiment includes a guidewire advancementassembly for selectively advancing a guidewire 122 that initiallyextends from within the housing 12 and into a lumen defined by thehollow needle 114. As best seen in FIGS. 6C and 7A, a proximal end ofthe guidewire 122 is attached to a guidewire hub 128 such that theguidewire extends distally into the flash chamber 117 and through theproximal end 114A of the needle 114 and into the lumen define by thehollow needle.

The guidewire hub 128 is attached to a guidewire advancement handle 120,best seen in FIGS. 6A and 7A. In greater detail, the guidewireadvancement handle 120 is slidably attached to the housing 112 via aslot 124 defined in the top housing portion 112A so as to selectivelyadvance or retract the guidewire 122 when the guidewire advancementhandle is slid distally or proximally, respectively, along the slot. Afinger pad 121 is included on the guidewire advancement handle 120 toenable a user of the device 10 to selectively slide the guidewireadvancement handle. As shown, the guidewire advancement handle includesan elongate body 170 that includes on its proximal end a raised portion172, configured here as a block that assists in preventing the elongatebody from falling through the slot 124. The guidewire hub 128 is alsodisposed on a proximal portion of the guidewire advancement handle body170 so as to be disposed within the housing 112, as best seen in FIG.6C. Note that the size, shape, position, and configuration of theguidewire advancement handle and finger pad can vary from what isexplicitly shown and described herein.

So configured, distal advancement of the guidewire 122 is accomplishedby a user placing a finger on the finger pad 121 of the guidewireadvancement handle 120 and sliding it from an initial proximal positionto a more distal position with respect to the housing 112. This distaladvancement of the guidewire advancement handle 120 also advances boththe guidewire hub 28, which is attached to the guidewire advancementhandle body 170, and the guidewire 122 itself such that a distal end122B thereof extends out of and distally past the distal end 114B of theneedle 114. Note that other guidewire advancement handle and finger paddesigns and configurations are possible in addition to those describedherein.

A needle retention assembly is also included and in the presentembodiment includes a needle retention component 40 to selectivelyenable retraction of the needle 114 into the housing after use of thedevice 10 so as to protect the user from an accidental needle stick. Inthe present embodiment, the needle retention component 40 includes tworetention arms 180 that extend radially outward and distally from theflash chamber 117 of the needle hub 116, as best seen in FIG. 8. Thelength of each of the retention arms 180 is such that they terminatedistal to the distal end of the housing 112. A hook 182 is included oneach retention arm 180. The hooks 182 are configured to engage withthreads 66 included on the hub 64 of the catheter assembly 60 so as toretain the catheter assembly in engagement with the device 10 during theinitial phases of the catheter insertion procedure. It is appreciatedthat the shape, size, and configuration of the retention arms and themanner of engagement with the catheter assembly and its hub can varyfrom what is shown and described herein.

The selective retraction of the needle 114 via actuation of the needleretention assembly described above is described here in connection withuse of the device 10 to insert a catheter or other suitable tubulardevice the body of a patient, according to one embodiment and asdepicted in FIGS. 7A and 7B. During operation, the needle 114 is firstused to pierce through an insertion site on the skin surface of thepatient and extend the distal end 114B of the needle into a subcutaneousvessel (or other intended destination). The guidewire advancement handle120 is then slid distally from its proximal position with respect to thehousing 112 so as to extend the guidewire 122 out the open distal end ofthe needle 114 and into the vessel. The guidewire 122 distally advancesin this manner until a distal portion of guidewire advancement handle120 impinges on a distal portion of the housing 112 and/or the distalend of the slot 124. Note that, in other embodiments, a lockingmechanism can be included so as to lock the guidewire advancement handleafter distal advancement so as to prevent inadvertent movement thereof.

The catheter assembly 60 can then be manually removed from the device 10and distally advanced from the device 10 and inserted into the vessel,guided by the needle 14 and the guidewire 22. The catheter is removed bythe user by manually twisting the catheter hub 64 so as to release thethreads 66 thereof from engagement with the hooks 182 of the retentionarms 180. A finger tab 190 included on the catheter hub 64, seen inFIGS. 6A and 7A, can be employed to assist the user in twisting thecatheter hub. The finger tab 190 can assist the user in twisting thecatheter hub 64 with the same hand that is grasping the device 10, inone embodiment. Once released in this manner, the catheter tube 62 canbe distally advanced into the vessel, as just described.

Engagement of the catheter hub threads 66 with the hooks 182 of theretention arms 180 prevents retraction of the retraction arms and,correspondingly, the needle hub 116 and attached needle 114. Upondetachment of the catheter assembly 60 from the retraction arms 180, asdescribed above, the needle hub 116 can now retract proximally withinthe housing, urged by the force of the spring 118, which can now expandfrom a compressed state (FIG. 7A) to an expanded state (FIG. 7B).Retraction of the needle hub 116 causes the corresponding retraction ofthe needle 114 into the housing 112 until the distal end 114B thereof isdisposed within the housing so as to prevent accidental needle sticks tothe user.

Despite retraction of the needle 114, the guidewire 122 remains in itsdistally extended state within the vessel. The catheter assembly 60 isdistally advanced into the vessel as desired, after which the device 10can be withdrawn from the patient, which causes removal of the guidewire122 from the vessel and insertion site. The catheter assembly 60 can bedressed as needed and the device 10 disposed of or otherwise safelyhandled.

FIGS. 9A and 9B depict various details of the catheter assembly 60 foruse with the catheter insertion device 10 described herein in connectionwith FIGS. 6A-8 or with other suitable catheter insertion devices. Asshown, the catheter hub 64 includes the finger tab 190, describedfurther above as a component to assist with twisting of the catheter hubby the user in order to separate the catheter assembly 60 from thedevice 10. As best seen in FIG. 9B, the finger tab 190 can include aprofile 192, such as rounded, as shown here. Other profiles are alsopossible, including squared, as shown in FIG. 10, or elongated as shownin FIG. 11. Of course, various other finger tab profiles are alsopossible.

In light of the above, in one embodiment, a catheter insertion device,such as the devices 10 described herein, can be manufactured in oneembodiment by providing a housing with a guidewire and a guidewireadvancement feature, such as the guidewire advancement assembliesdiscussed herein, including the guidewire advancement handles 20, 120and associated components. A needle is also provided so as toretractably extend from the housing, and a catheter assembly isremovably disposed on the needle. A needle retention assembly is alsoincluded with the catheter insertion device, such as the needleretention component 40 described above, for enabling selectiveretraction of the needle into the housing to prevent accidental needlesticks.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A method of inserting a catheter into a bloodvessel, comprising: accessing a catheter insertion device comprising: ahousing; a needle including a needle hub, a needle lumen, and a needletip, the needle hub having a portion in the housing; a catheter coupledto a catheter hub, the catheter positioned over the needle such that aneedle tip extends past a distal end of the catheter; a guidewire havinga distal end; a guidewire handle coupled to the guidewire, the guidewirehandle including a finger pad positioned on a surface of the housing;and a pair of retention arms that extend from the needle hub, wherein adistal portion of each of the pair of retention arms extends distally ofthe housing, the distal portion of each of the pair of retention armsengaging the catheter hub; inserting the needle tip and the distal endof the catheter into the blood vessel; sliding the finger pad from afirst position, in which the distal end of the guidewire is disposed inthe needle lumen, to a second position, in which the distal end of theguidewire extends past the needle tip; moving the catheter hub out ofengagement with the pair of retention arms; and advancing the catheterover the guidewire into the blood vessel.
 2. The method of insertingaccording to claim 1, wherein the catheter insertion device furthercomprises a spring in the housing, wherein moving the catheter hub outof engagement with the pair of retention arms permits the spring toretract the needle into the housing.
 3. The method of insertingaccording to claim 2, wherein the catheter insertion device furthercomprises a flash chamber coupled to the needle hub, the flash chamberhaving a diameter greater than a diameter of the needle hub, wherein thespring is positioned over the needle hub in the housing, and wherein thespring is compressed between the flash chamber and the housing.
 4. Themethod of inserting according to claim 1, wherein moving the catheterhub out of engagement with the pair of retention arms comprises rotatingthe catheter hub.
 5. The method of inserting according to claim 4,wherein the catheter hub includes a finger tab to facilitate rotatingthe catheter hub.
 6. The method of inserting according to claim 1,wherein each of the steps: accessing the catheter insertion device,inserting the needle tip and the distal end of the catheter into theblood vessel, sliding the finger pad from the first position to thesecond position, and sliding the finger pad from the second position tothe third position, is performed using a single hand without removingthe single hand from the catheter insertion device.